@jennifer-carroll Thank you for your response. Am I correct in understanding that disease information would then likely be removed if it does not align to the part 3 of the TMA and should instead be submitted as patient information?
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xian50
@xian50
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Disease information in Risk Management Materials -
Disease information in Risk Management MaterialsWould it be possible to include basic disease information (ie what is x condition? how does it work? What are symptoms? etc) in patient-directed risk management materials? We may need to include it based on requirements from our global company's risk management program. We would anyways be submitting the piece for PAAB review/exemption however it would be good to know in advance.